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I N S T A L L A T I O N A N D U S E R G U I D E
• Do not modify this equipment in any way .
• Never use the system in the presence of flammable or explosive gases.
It is critically important that only MR Safe and MR Conditional components be taken into and installed in the MRI suite .
When installed correctly, the MRIaudio Sound System is MRI-compatible and will produce high-quality audio for patients
undergoing MRI scans .
INDICATIONS FOR USE
The MRIaudio Sound System is intended to provide audio entertainment and facilitate patient communication in MRI
environments up to, and including, 3 .0 Tesla . The product is not intended for medical diagnosis or treatment . Technologist
control units are intended to be used outside of the MRI scan room .
WARNING: Portable RF communications equipment including peripherals such as antenna cables and external antennas
should be used no closer than 12 inches (30 cm) to any part of the MRIaudio Sound System or cables . This could result in
a performance degradation of the system .
WARNING: Use of accessories, cables, and other equipment not specified or provided by MRIaudio could result in
increased electromagnetic emissions or decreased electromagnetic immunity of the equipment and result in improper
operation .
WARNING: Use of system equipment adjacent to or stacked with other equipment should be avoided . This could result
in improper operation . If this scenario is necessary, the equipment should be observed to verify the system is operating
normally .
NOTE: The emissions characteristics of this system equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A) . If used in a residential environment (for which CISPR 11 class B is normally required), this equipment
might not offer adequate protection to radio-frequency communication services . The technologist might need to relocate
or re-orient the equipment .
CLEANING
Device components can be cleaned with a dampened small cloth with rubbing alcohol or hand sanitizer . Do a quick wipe
over the surface of the devices as well as the wires . For the Over-Ear Headphones, clean the ear cups with a sanitizing
wipe . To avoid patient cross contamination, replace the headphone cloth covers after each scan session . For the In-Ear
Headphones, clean the entire plastic wishbone with a sanitizing wipe . Replace the foam ear tips after each scan session .
EMERGENCY PROCEDURE
In the unlikely event that either the MRIaudio Sound System or any component creates smoke, sparks, or if the patient
requires emergency assistance:
• Stop the scan immediately if one is in progress .
• Remove the headphones from the patient .
• Remove the patient from the scan room if medical treatment is needed .
REPORTING INCIDENTS
Contact MRIaudio immediately to report an incident and/or injury to a patient, operator or maintenance employee that
occurred while using the MRIaudio Sound System . Do not operate the equipment until an investigation is conducted .
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IM-1505 Rev. D
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